| CTRI Number |
CTRI/2024/06/069283 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prediction of difficult laryngoscopy by ultrasound measurement of face and neck parameters in adult patients. |
|
Scientific Title of Study
|
ULTRASOUND BASED ASSESSMENT OF TONGUE THICKNESS, SKIN TO HYOID BONE DISTANCE AND SKIN TO EPIGLOTTIS DISTANCE IN PREDICTING DIFFICULT LARYNGOSCOPY IN ADULT PATIENTS. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kushal Dabas |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi India
New Delhi
DELHI
110029
India
South DELHI 110029 India |
| Phone |
8130034071 |
| Fax |
|
| Email |
kushal.dabas@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Anjali Kochhar |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi
New Delhi
DELHI
110029
India
South DELHI 110029 India |
| Phone |
9999197721 |
| Fax |
|
| Email |
dranjalikochhar@vmmc-sjh.nic.in |
|
Details of Contact Person Public Query
|
| Name |
Anjali Kochhar |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi
New Delhi
DELHI
110029
India
South DELHI 110029 India |
| Phone |
9999197721 |
| Fax |
|
| Email |
dranjalikochhar@vmmc-sjh.nic.in |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kushal Dabas |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anaesthesia,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi
New Delhi
DELHI South DELHI |
8130034071
kushal.dabas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-65years, undergoing elective surgery under general anaesthesia requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1) Anticipated difficult airway requiring planned awake intubation.
2) Front of neck access not available. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the role of ultrasound based assessment of combination of tongue thickness, skin to hyoid bone distance and skin to epiglottis distance in predicting difficult laryngoscopy in
adult patients, using Cormack Lehane grading. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare ultrasound based assessment of combination of tongue thickness, skin to hyoid bone distance & skin to epiglottis distance with each individual parameter in predicting difficult laryngoscopy in adult patients undergoing elective surgery. |
At the time of induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Difficult intubation is an emergency situation and an important procedural step during anaesthesia, and failure to anticipate difficult intubation can have serious consequences like local injury, hypoxia, need of putting surgical airway, arrhythmia, cardiac arrest and death. The incidence of difficult laryngoscopy and tracheal intubation still ranges between 1.5%-13%.
An accurate pre-operative assessment therefore provides comprehensive planning and management for reducing the risk of unanticipated difficult airway. However, common clinical evaluation measurements (e.g. the modified Mallampati test, thyromental distance, inter-incisor distance, cervical mobility, sex, body mass index, etc.) have limited value with unsatisfactory sensitivity and specificity.
Tongue thickness assessed by USG gives us an internal characteristic of a patients upper airway and helps us in predicting difficult laryngoscopy. It will be determined by placing curvilinear ultrasound probe one end against top of the mandible and other end to the sternum. Skin to epiglottis distance tells us about width of anterior soft tissue of neck at the level of thyrohyoid membrane. It will be determined by placing linear probe at thyrohyoid membrane level, the distance from skin to epiglottis midway between the hyoid bone and thyroid cartilage is measured.
Skin to hyoid bone distance tells us about the anterior soft tissue thickness of neck at the level of hyoid bone. The hyoid bone is identified by placing the linear ultrasound probe transversely over the hyoid bone. It appears as curved echogenic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space. At hyoid bone level, the minimal distance from skin to hyoid bone will be measured.
However, difficult airway is not determined by a single anatomical factor, and the sensitivity and specificity of a single index for airway prediction are not ideal. Also, there is a paucity of data on the role of ultrasound measurement of combination of airway parameters in predicting difficult laryngoscopy in adult patients.
The purpose of this study is to evaluate the role of ultrasound based assessment of tongue thickness, skin to hyoid bone distance and skin to epiglottis distance in predicting difficult laryngoscopy in adult patients. |